Unravelling code of genetic patents

In May, the European Parliament voted in favour of the Directive on the Legal Protection of Biotechnological Inventions - the so-called Biotech Directive.

After years of vigorous debate, and the European Parliament's rejection of the previous draft in 1995, the Council of Ministers adopted the directive on 16 June. It came into force on 30 July and member states have until 30 July 2000 to implement its provisions.

The directive is a sensible compromise between the views of the biotech industry and the ethical concerns surrounding the direction of genetic research. But how will the directive affect European patent law in biotechnology?

The directive consists of 16 articles, and 56 recitals set out detailed provisions of what will be patentable across the biotech spectrum. It generally confirms existing EU patent law, with clarification of some areas of uncertainty and controversy (such as transgenic animals and isolated genes) in favour of patentability. The directive also gives guidance on inventions considered to go against morality.

Before considering the directive's details, it must be remembered that for any patent to be granted, the standard criteria must still be met - namely, there must be an invention. It cannot be a mere discovery. It must be new, involve an inventive step and have an industrial application.

Article 5 of the directive recognises that a natural element from the human body may be patentable if it has been isolated for the first time. It states that "the human body, at the various stages of its formation and development" cannot be patented. However, an element (including a gene) "isolated from the human body or otherwise produced by means of a technical process" can be patented, "even if the structure of that element is identical to that of a natural element".

Therefore, while the body and the simple discovery of one of its elements, such as a gene sequence, cannot be patented, an element isolated from the human body or otherwise produced by means of a technical process can be patented even if the structure of that element is identical to that of a natural element.

The industrial application of a gene sequence will have to be disclosed in any patent application. No patent will be granted for a gene sequence without indication of a function, thereby ending the ongoing debate on that subject.

The recitals indicate that information about the geographical origin of the animal or plant material on which an invention is based should, "where appropriate" and if known, be included in the patent application. Where the material is of human origin, the person from whose body it is taken should be given the opportunity to give free and informed consent to an application for a patent.

This confirms patentability of proteins with defined functions (such as human growth hormone and insulin) produced by recombinant DNA technology - which is already established European Patent Office (EPO) practice.

Article 6 confirms existing European patent law by stating that inventions "contrary to public order or morality" will not be patentable. Examples of such processes include cloning human beings and "processes for modifying the germ-line genetic identity of human beings".

The advantage of this level of detail is that it clarifies present uncertainties and may speed up lengthy oppositions at the EPO. However, one questions remains: for how long can such detail remain useful in view of the speed with which technology is moving?

The recent application made to the US Patent Office on human/animal chimeras (or hybrids) illustrates this point. The directive (recital 38) specifically excludes such chimeras from patentability. While this may be helpful in this instance, it may have been better to allow existing regulations - for example, the Human Fertilisation and Embryology Act 1990 - to regulate inventions in this sphere.

Plant and animal varieties will stay unpatentable (Article 4). However, an invention concerning plants or animals will still be patentable if the application of the new invention is not confined to a single plant or animal variety.

The directive also makes it clear that transgenic animals and plants are patentable. But the directive outlaws transgenic patents where it is "likely to cause suffering without any substantial medical benefit to man or animal".

This is a particularly welcome clarification because the EPO has a backlog of numerous transgenic animal and plant patents. As with the existing law, no patent is to be granted for a process that is "essentially biological", such as procedures involving crossing or selection.

It is also welcome that the Swiss nationwide referendum on genetic engineering, held in June, rejected proposals to impose stringent restrictions on genetic research. Had the vote gone the other way, the research and patenting of genetically modified plants and animals would have been prohibited.

Although not a member of the EU, Switzerland is a member of the European Patent Convention (EPC). If the Swiss had voted in favour of restrictions, it would have gone against the provisions of the new directive on transgenics and created an unhelpful conflict among EPC members.

Articles 9 and 11 provide for the so-called "Farmer's Privilege" in respect of both plants and animals. Sale of "plant-propagating material" to a farmer by a patentee is to imply, subject to certain conditions, authorisation to the farmer to use the product of his harvest for propagation by him on his own farm.

Similarly, the sale by a patentee of "breeding stock or other animal reproductive material" to a farmer will - to an extent to be determined by member states - imply authorisation for the farmer to use the livestock for "agricultural purposes" (which excludes the sale within a commercial reproduction activity).

The time has now come to embrace the directive. Uncertainties in this area have been unhelpful, allowing lobby groups to undermine biotechnology patents. These uncertainties have allowed lengthy oppositions to granted patents.

An illustration of this is the case of the Harvard Oncomouse, a breed of mouse containing cancer genes produced at Harvard University in the US to carry out research into cancer. The European patent application was filed in 1985 and 13 years later the patent is still being opposed at the EPO on morality grounds by 17 groups, including animal rights campaigners and environmentalists.

The directive, in the main, confirms existing EU patent law. However, it will also provide the clarification which is badly needed to help patent offices across Europe decide what is patentable in the field of biotechnology. It should reduce the controversy surrounding patents in this area and will speed up the time it takes for patents to be granted. It is therefore a welcome boost to those engaged in biotech research and development.